A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced HRD-Negative Ovarian Cancer Following First0line Platinum-based Chemotherapy

The purpose of this study is to investigate how well and how safely a drug called Sacituzumab Tirumotecan (also referred to as sac-TMT or MK-2870) works as a subsequent treatment for patients who have recently been diagnosed with advanced ovarian cancer without a specific genetic feature known as HRD. This treatment is administered after conventional first-line chemotherapy with platinum-based drugs. MK-2870 is an experimental drug that consists of a monoclonal antibody combined with a toxin (KL610023) and is also referred to as an antibody-drug conjugate or ADC. Antibodies are proteins produced by the immune system to fight foreign substances such as bacteria or viruses, as well as tumors. Monoclonal antibodies bind to specific targets on cells. MK-2870 binds to a target on certain cancer cells known as Trophoblast Antigen 2 (TROP2). Through this binding, the toxin (KL610023) can damage these cancer cells. MK-2870 is not yet approved in Switzerland and is currently being investigated in various studies for the treatment of multiple diseases. As standard therapy for the first treatment cycle, you will receive a platinum-based chemotherapy with or without Bevacizumab. As a subsequent treatment in the study, you will receive sac-TMT with or without Bevacizumab, only Bevacizumab, or you will be observed. It is expected that approximately 900 patients worldwide will participate in this study. About 25 patients will participate in Switzerland. The total study duration is approximately 7 years.

Inclusion Criteria:

- You have advanced ovarian cancer (stage III or IV) or a similar cancer originating in the peritoneum or a fallopian tube. This includes various types of ovarian cancer, such as high-grade serous cancer, endometrioid cancer, carcinosarcoma, mixed types with high-grade serous components, clear cell carcinoma, or low-grade serous cancer.

- You have undergone a first surgical procedure (primary debulking surgery) before chemotherapy or an operation (interval debulking surgery) after neoadjuvant chemotherapy. 

You must have completed at least 4 cycles of platinum-based chemotherapy as first-line treatment but must not have received more than 6 cycles.

Inclusion Criteria:

You have advanced ovarian cancer (stage III or IV) or a similar cancer originating in the peritoneum or a fallopian tube. This includes various types of ovarian cancer, such as high-grade serous cancer, endometrioid cancer, carcinosarcoma, mixed types with high-grade serous components, clear cell carcinoma, or low-grade serous cancer. 

You have undergone a first surgical procedure (primary debulking surgery) before chemotherapy or an operation (interval debulking surgery) after neoadjuvant chemotherapy. 

You must have completed at least 4 cycles of platinum-based chemotherapy as first-line treatment but must not have received more than 6 cycles.